Validation Protocol and Report Procedure | ISO 13485 | FDA QMSR

Structure medical device validation protocols and final reports with this editable ISO 13485 procedure. It covers the content of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Product Performance Qualification (PPQ) documents, including results, deviations, approval and record control.

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Supplied as one editable Microsoft Word document in a digital download.

IQ, OQ, PQ and PPQ protocol and report structure

The Validation Protocol and Report Procedure instructs on the development of Installation Qualification (IQ) Protocols, Operational Qualification (OQ) Protocols, Performance Qualification (PQ) Protocols and Product Performance Qualification (PPQ) Protocols. The Validation Protocol and Report Procedure also provides instruction on the format and required content of all validation final reports.

• IQ, OQ, PQ and PPQ protocol content

• Qualification report structure and results

• Deviation, approval and document-control requirements

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

Pair this document with the Process Validation Procedure for overall planning and the Installation Qualification Procedure for equipment installation activity.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Process Validation: Protocols, Statistics and Mold Processes for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in ISO 13485 Process Validation Procedure Bundle. Explore the bundle for the related documents.